BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT

    MDR report key: 2292997 · Received October 13, 2011

    Report

    Report Number
    2649622-2011-15818
    Event Type
    Malfunction
    Date Received
    October 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED THAT TWO LEAD INTEGRITY ALERTS TRIGGERED, WITH 2 - PATIENT ALERTS FOR LEAD FAILURE PREDICTOR ON (B)(6) 2011 21:36:10 AND (B)(6) 2011 07:16:44. THERE WAS ALSO OVERSENSING, WITH 5 - VENTRICULAR NST <=180 MS BETWEEN (B)(6) 2011 21:35:20 AND (B)(6) 2011 09:50:25. IN ADDITION, THERE WAS INTERFERENCE/NOISE, WHERE THE VENTRICULAR SHORT INTERVAL COUNT V-SIC=2.7 COUNTS AVG/DAY, IN 49.94 DAYS, BETWEEN (B)(6) 2011 09:24:18 AND (B)(6) 2011 08:01:51.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD SHOWED OVERSENSING AND NOISE. THE PHYSICIAN WILL CHECK THE PATIENT AGAIN. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6945 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other 5568 IMPLANTABLE PACING LEAD| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD